MedTrace Logo

Effects of Cannabis/Alcohol on Driving Performance and Field Sobriety Tests

NCT05273658 · Status: WITHDRAWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL

Last updated 2023-09-07

No results posted yet for this study

Summary

The overarching aim of this study is to examine the impact of acute cannabis and alcohol administration on driving performance, as well as identify methods for detecting driving under the influence of these substances. One-hundred twenty-five healthy volunteers will be randomized into one of 5 conditions; those who receive 1) low dose alcohol and placebo cannabis, 2) low dose alcohol and tetrahydrocannabinol (THC), 3) high dose alcohol and placebo cannabis, 4) placebo alcohol and THC, and 5) double placebo. Cannabis inhaled ad libitum and/or ingested alcohol will take place at the beginning of the day followed by the completion of driving simulations, components of the Drug Recognition Expert (DRE) evaluations, and bodily fluid draws (e.g., blood, oral fluid/saliva, breath) over the subsequent 4 hours after ingestion. The purpose of this study is to determine (1) the impact of Δ9-THC on driving performance with and without concurrent alcohol ingestion (2) the duration of driving impairment in terms of hours from initial use, (3) the relationship between performance on the DRE measures and cannabis/alcohol ingestion, and 4) if saliva or expired air can serve as a useful adjunct to the field for blood sampling.

Conditions

  • Driving Impaired
  • Alcohol Intoxication
  • Driving Under the Influence
  • Cannabis Intoxication

Interventions

DRUG

Cannabis

Participants will smoke a cannabis cigarette ad libitum as per their usual routine

DRUG

Alcohol

Participants will ingest alcohol to achieve the target breath alcohol level

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
SCREENING
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-08-31
Primary Completion
2023-06-30
Completion
2023-06-30
FDA Drug
Yes

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05273658 on ClinicalTrials.gov